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A study of medication errors in a tertiary care hospital

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DOI: 10.4103/2229-3485.192039

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Original Article

Nrupal Patel, Mira Desai1,

Samdih Shah1, Prakruti Patel1, A study of medication errors in a
tertiary care hospital
Anuradha Gandhi1

Department of Pharmacology,
Government Medical College, Surat,
1
Department of Pharmacology,
B. J. Medical College, Ahmedabad,
Gujarat, India

Address for correspondence:

Dr. Mira Desai,
Department of Pharmacology,
B. J. Medical College,
Ahmedabad ‑ 380 016, Gujarat, India.
E‑mail: desaimirak@yahoo.co.in

Ab stract Objective: To determine the nature and types of medication errors (MEs), to evaluate
occurrence of drug‑drug interactions (DDIs), and assess rationality of prescription orders
in a tertiary care teaching hospital. Materials and Methods: A prospective, observational
study was conducted in General Medicine and Pediatric ward of Civil Hospital, Ahmedabad
during October 2012 to January 2014. MEs were categorized as prescription error, dispensing
error, and administration error (AE). The case records and treatment charts were reviewed.
The investigator also accompanied the staff nurse during the ward rounds and interviewed
patients or care taker to gather information, if necessary. DDIs were assessed by Medscape
Drug Interaction Checker software (version 4.4). Rationality of prescriptions was assessed
using Phadke’s criteria. Results: A total of 1109 patients (511 in Medicine and 598 in Pediatric
ward) were included during the study period. Total number of MEs was 403 (36%) of which,
195 (38%) were in Medicine and 208 (35%) were in Pediatric wards. The most common ME
was PEs 262 (65%) followed by AEs 126 (31%). A potential significant DDIs were observed
in 191 (17%) and serious DDIs in 48 (4%) prescriptions. Majority of prescriptions were
semirational 555 (53%) followed by irrational 317 (30%), while 170 (17%) prescriptions were
rational. Conclusion: There is a need to establish ME reporting system to reduce its incidence
and improve patient care and safety.
Key words: Medication errors, medicine, Medscape Drug Interaction Checker, pediatric,
Phadke’s criteria

INTRODUCTION or patient harm, while the medication is in the control

The National Coordinating Council for Medication Error
Reporting and Prevention  (NCCMERP) has defined
medication errors (MEs) as, “Any preventable event
that may cause or lead to inappropriate medication use
Access this article online
Quick Response Code:
Website:
of the health care professional, patient, or consumer.”[1]
American Society of Hospital Pharmacists guidelines
for MEs stated that incidence of MEs is not exactly
known because of variations in different definitions
This is an open access article distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
others to remix, tweak, and build upon the work non‑commercially, as long as the
author is credited and the new creations are licensed under the identical terms.

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For reprints contact: reprints@medknow.com

DOI:
How to cite this article: Patel N, Desai M, Shah S, Patel P, Gandhi A.
10.4103/2229-3485.192039 A study of medication errors in a tertiary care hospital. Perspect Clin
Res 2016;7:168-73.

© 2016 Perspectives in Clinical Research | Published by Wolters Kluwer ‑ Medknow 168

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Patel, et al.: Medication error in tertiary care hospitals
of ME, different methods, or subject populations.[2]
In India, studies done in Uttarakhand and Karnataka
have documented ME rate to be as high as 25.7%
and 15.34%, respectively, in hospitalized patients. [3,4]
Unfortunately, most of the MEs remain undetected,
if clinical significance or outcome does not adversely
affect the patient. While some of the MEs also result
into serious morbidity or mortality and have a significant
economic impact on the patient and health care system.
The Institute of Medicine estimated costs due to medical
errors in the US of was approximately $37.6 billion/year.
About $17 billion of it are associated with preventable
errors.[5] Overall, MEs increase morbidity, mortality, and
economic burden to health care system.
Drug‑drug interactions (DDIs) are defined as combining
two or more drugs in such a way that the potency or
efficiency of one drug is significantly modified by the
presence of another. [6] DDIs account 6–30% of all
adverse drug events and can increase occurrences of ME.
Furthermore, self‑medication, poor communications
between the prescriber and the patient, and even demand of
the patient for medicine for each symptom, unethical drug
promotion and inducements increases irrational prescribing.
[7]
This increase the number of drugs per prescription which
may lead to ME and DDIs. Hence, monitoring of DDIs and
rationality plus ME would be an essential element of high
quality of medical care. The data about these are lacking in
our hospital, hence the present study was carried out with
the objectives to determine demography about MEs, DDIs,
and rationality of prescriptions.
MATERIALS AND METHODS
An observational, prospective study was conducted in a unit
of General Medicine and Pediatric Ward at Civil Hospital,
Ahmedabad from October 2012 to January 2014. The study
was approved by Institutional Ethics Committee (approval
number ‑ 20/13). All patients admitted to one specific unit
of General Medicine and Pediatric ward were included
while patients shifted to other wards were excluded. Chart
review and direct observation method were used to detect
MEs. The NCCMERP guidelines 2010 definitions were
used for MEs.[1] Direct observation was also carried out
by investigator, who accompanied the staff nurse during
medication administration round. If necessary, investigator
also interviewed patients or care taker to gather information.
For MEs patients were followed up till discharge. DDIs
were assessed by Medscape Drug Interaction Checker
software (version - 4.4 available on: http://www.reference.
medscape.com/drug-interactionchecker. Developed by
Medscape). According to software, DDIs were classified
as minor  (non-significant) that do not require patient
monitoring, major (significant) which require monitoring,
169
and serious DDIs in which a medical intervention is
required. Rationality of prescription orders was assessed
using Phadke’s criteria.[8] And, standard text books of
Medicine and Pharmacology. Based on these criteria,
each prescription was allocated 30 points. Out of which,
prescription scoring between 0 and 14 were categorized as
irrational, 15–24 semi‑rational, while prescriptions scoring
between 25 and 30 were categorized as rational.
RESULTS
A total number of 1147 (529 in Medicine and 618 in
Pediatric) patients were enrolled during study period.
Among them, 38 were not included due to discharged
against medical advice (15), death (11), transferred to
other wards  (9), and absconded  (3). Hence, a total of
1109 patients were included in the study, of which,
511 were from Medicine and 598 from Pediatric ward. Total
403 (36%) MEs were detected, among which 195 (48%)
were in Medicine and 208 (52%) were in Pediatric wards.
Demographic details
Mean Age of the patient including in study was
42.28 ± 0.82 years in Medicine and 4.5 ± 0.67 years in
Pediatric ward. Age group between 12–32 years (71, 36%)
and <1 year had the highest number of MEs (67, 32%).
Majority of MEs were observed with intravenous (IV)
route (368, 91%) followed by oral (26, 6%). In addition
majority of MEs were observed with male (123, 67%)
in Medicine ward and boys (111, 53%) in Pediatric ward.
Most common drug group all MEs was antibacterial in
both wards [Table 1].
Medication errors
A total of 403 MEs occurred during the study period
[Table 2]. Out of 403, 262 were prescription errors (PEs).
Majority of them (260, 99%) were inappropriate selection
of medicine. Antibacterial (181, 70%) was the most
common inappropriately prescribed drug group followed
by gastrointestinal (GI) (79, 30%). Ceftriaxone (89),
co‑amoxiclav  (41), metronidazole  (40), chloroquine  (6),
Table 1: Common drug groups involved in
medication errors
Drug group Medicine Paediatric
ward (n=195) ward (n=208)
Antibacterial drugs 105 106
Drugs used in 9 16
cardiovascular diseases
Drugs used in 70 14
Gastrointestinal diseases
Vitamins 1 31
Intravenous Fluids 5 32
Others 5* 9 **
*Atropine, antiplatelets, β2 agonist, insulin. **β2 agonist, NSAIDs, antiepileptic
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Patel, et al.: Medication error in tertiary care hospitals

and gentamicin (5) were among antibacterial group, while Out of 1109 prescriptions, 508 (46%) had the presence of
ondansetron (54) and ranitidine (25) from GI group, which potential DDIs. Majority of DDIs were nonsignificant (269,
were inappropriately prescribed. 53%) followed by significant (191, 38%). While
48 (9%) of DDIs were serious [Figure 1]. In potential
Out of 403 MEs, dispensing errors (DEs) were seen significant DDIs, cardiovascular (CVS) drugs were most
in 15 patients. The prescribed medicines were not commonly involved (108) followed by antibacterial (30)
dispensed and thus had consequences of omission. Out hypolipidemics (26) antiepileptic (20) and anticoagulants (7)
of 15 omissions, there was one death due to missed dose [Table 4].
of atropine in organophosphates poisoning.
Rationality of each prescription was assessed using Phadke’s
A total of 126 (31%) medicine administration errors (AEs) criteria. Out of 1109 prescriptions, 1042 were assessed
were observed during the study period. Of these, 72 were for Rationality as. In (67) prescription diagnosis was not
incorrect dose administration (either lower or higher than mentioned was excluded from rationality assessment. The
the prescribed), 38 were inaccurate dosing interval (not mean rationality score was 21.4 ± 5.2 (mean ± standard
as per specified time interval), and wrong route of deviation). Majority of prescriptions (555, 53%) scored
administration (oral instead of IV) was detected in 15 and between 15 and 24 points and were categorized as
medicine administration to the wrong patient was observed semi‑rational. While 317 (31%) scored between 0 and 14
in one patient [Table 3]. points, thus categorized as irrational. However, 170 (16%)
prescriptions scored between 25 and 30 points and thus
Table 2: Types of medication errors (n=403) were rational [Figure 2].
Type of error No. of error (%)
Prescription errors 262 (65) Non significant
Inappropriate selection of medicine 260 (269)
Incomplete medical history of patient 02
Dispensing errors 15 (4) DDIs Signficant
Omission 15 (508) (191)
Administration errors 126 (31) Clinically observed
Inaccurate dose 72 (2)
Serious
Error in dosing interval 38
(48)
Wrong route of administration 15 Potential
Wrong patient 01 (46)
Total number of medication errors 403 (100)
Figure 1: Categorization of Drug-Drug Interactions

Table 3: Type of medicine administration errors (n=126)

Type of error Medicines Number of medicines
Inaccurate dose (n=72) Extra or high dose Low dose
IV fluid (24) 13 11
Multivitamins (18) 7 11
Furosemide (17) 10 7
Co amoxiclav (8) 4 4
Salbutamol (3) 1 2
Enalapril (2) 2 0
Errors in dose interval (n=38) Early Late
IV Fluid (12) 4 8
Ceftriaxone (10) 2 8
Co‑amoxiclav (5) 2 3
Metronidazole (3) 0 3
Mannitol (3) 1 2
Vitamin‑D3 (2) 1 1
Insulin (2) 1 1
Gentamicin (1) 0 1
Wrong route of administration (n=15) Oral to IV IV to oral Tablet to syrup
Zinc (9) 0 0 9
Ranitidine (4) 1 3 0
Paracetamol (2) 0 2 0
Wrong patient (n=1) Diagnosis Wrongly administered
Pneumonia Calcium
IV=Intravenous

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Patel, et al.: Medication error in tertiary care hospitals

DISCUSSION more affected in MEs in medicine ward, while a study

The goal of medication use is to achieve defined therapeutic
outcomes with improvement of quality of life and minimize
patient risk.[9] ME can occur at any phase of medication use
cycle from prescribing, dispensing, and administration of
a drug to the patient. It increases morbidity and mortality
of the population along with increase in the cost of the
treatment. Further, it also affects patient’s confidence in
medical care.[10,11]
MEs are common in hospitalized patients at a rate of 5
per 100 medication prescriptions or 1.4 per admission.[12]
Pediatric population is vulnerable with the risk of 6 MEs
per 100 admissions.[13] Our study observed 36% of ME
while a study in France reported 27.6% of MEs.[14] Our
observations are comparable to a study done at Indore.[15]
Present study showed that 12–32 years of age group was
16%
31%
Irrational
Semirational
Rational
53%
done in Delhi reported that 28–38 years of age group was
commonly involved.[16] On the contrary, Pote et al. reported
that more than 60 years had high number of MEs.[17] While
in case of pediatric ward, <1 year of age group had high
number of MEs, which is comparable to a study done in
Saudi Arabia.[18] This is alarming as infants (<1 year) are
vulnerable population for medicine AEs such as wrong
dose, wrong route of administration, or use of off‑label
drugs. In addition, pharmacokinetic or pharmacodynamic
of drugs also differ in this patient population. This calls for
a need to monitor ME in pediatric wards and educate the
stakeholders. In our study, males were more affected from
MEs which is comparable to an Indian study conducted in
Karnataka in Medicine and surgery wards and Al‑Jeraisy
et al. in Pediatric ward in Saudi Arabia.[4,18] In present study,
IV route of administration was involved with MEs which
is supported by a study in Karnataka in Medicine and
Surgery departments and also by Ross et al. in Pediatric
department.[4,19] This suggests that MEs are commonly
associated with IV route.
The most common drug group involved in MEs in
Medicine ward was antibacterial followed by GI group,
CVS group and IV fluids. This could be because a
significant number of patients were hospitalized due to
infectious diseases and CVS diseases. While GI drugs
such as ranitidine and ondansetron have been prescribed
inappropriately, anticipating gastritis and vomiting in these
patients. Our finding have been supported by a study done
in medical wards of tertiary care teaching hospital where
ME with anti‑bacterials is highest.[17,18]

Inappropriate selection of medicines is one of the most

Figure 2: Rationality of prescription common prescribing errors. According to standard text

Table 4: Drugs responsible for DDI

Significant DDIs Effect Type of interaction (PK/PD) No. of DDIs (n=126)
Atenolol + Amlodipine Increased antihypertensive effect PD 15
Heparin + Clopidogrel Increased anticoagulant effect PD 12
Spironolactone + Furosemide Fluctuations in potassium level PD 12
Aspirin + Atenolol Hyperkalemia PD 12
Enalapril + Aspirin Increased renal toxicity PD 11
Furosemide + Digoxin Increases antihypertensive effect PD 10
Atorvastatin + Digoxin Statin increases level of digoxin PK 10
Aspirin + Clopidogrel Increased anticoagulant effect PD 8
Aspirin + Spironolactone Hyperkalemia PD 7
Aspirin + Digoxin Hyperkalemia PD 4
Spironolactone + Digoxin Hyperkalemia PD 5
Dexamethasone + Ondansetron Steroid decreases effect of ondansetron PK 5
Atenolol + Digoxin Hyperkalemia PD 4
Propranolol + Spironolactone Fluctuations in potassium level PD 4
Enalapril + Furosemide Increased antihypertensive effect PD 3
Enalapril + Digoxin Enalapril increases level of digoxin PK 2
Atorvastatin + Spironolactone Spironolactone increases level of Atorvastatin PK 2
PK=Pharmacokinetic, PD=Pharmacodynamic

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Patel, et al.: Medication error in tertiary care hospitals
and reference books, we differentiated between appropriate
and inappropriate medicines. Based on that, we found
that antibacterial was the most commonly inappropriately
prescribed drug group. That may increase chance of
antibacterial resistance and also cost of the treatment. DEs,
especially omission was detected in both the wards. The
consequences of missed drug dose are difficult to predict as
it varies with clinical disease, condition of the patients, and
pharmacokinetics of drug. A wide variation in DEs from
4.7% to 33% has been observed by Gaur et al. and Kumar
et al., respectively. Both the studies had similar dispensing
system as our study.[3,4] However, 1–1.7% of DEs have
been observed in hospitals following unit dose dispensing
system.[20,21] This system reduces the chances of dose errors.
Our study showed that the most common medication
AEs were inaccurate dose followed by inaccurate dosing
interval. Studies done by Kumar et al. reported 17.4%,
while Agarwal and Joshi reported 45.5% dose errors.[4,16]
A study in Saudi Arabia showed 47.3% overdose errors.[19]
It has been documented in a study done by Parihar and
Passi et al. that IV fluid administration is involved with
wrong rates worldwide.[15] The reason for inaccurate dose
administration is due to poor communication between
health care professional team, missed labeling of IV fluid,
and improper use of instruments. An inaccurate dosing
interval error was observed in our study which is higher
than the reported by Kumar et al.[4] Busy schedule, urge
to complete work as early as possible, and missing double
check/cross checking of prescription orders can lead to
wrong route of administration. These reasons not only
increase the patient risk, but also increase the cost of
treatment.
Our study showed the presence of potential significant
and serious DDIs in the prescriptions from Medicine
and Pediatric ward. Potential significant DDIs were more
common with CVS drugs such as atenolol, enalapril,
digoxin, and furosemide. The risk of DDI was significant
due to multiple drug therapy along with co‑morbidities in
patients more than 40 years of age. Similar observations
have been reported by Patel et al. and Sepehri et al.[22,23]
Surprisingly, nine serious reactions were observed with
ondansetron. However, their potential to cause serious
DDI has been neglected by prescribers. This calls for
educating prescribers regarding DDI and undertaking
prescription audit on regular basis.
Prescribing of medications outside the accepted medical
standards is known as an inappropriate prescribing.[24] In
present study, PEs were evaluated using Phadke’s criteria.
To our satisfaction, majority of the prescriptions were
semi‑rational in both Medicine and Pediatric wards. This
suggests that majority of the prescriptions had appropriate
Perspectives in Clinical Research | October-December 2016 | Vol 7 | Issue 4
drugs with correct dosage instructions. However, there
were few irrational prescriptions (31%) with unnecessary
drugs such as ondansetron, ranitidine, multivitamins, folic
acid, ceftriaxone, and metronidazole. A study done by Shah
et al. observed 28.3% irrational prescriptions which is less
as compared to our findings.[8]
Our study had few limitations such as we were not able to
record MEs on public holidays and Sundays. Furthermore, we
could not assess the actual impact of DDIs and while assessing
the rationality and DDIs, the clinicians’ viewpoint was not
taken into account, which could have been different than ours.
CONCLUSION
Our study shows the occurrence of MEs at each phase
of medication use cycle. Along with potential DDIs and
semi‑rational prescriptions. Probably, computerizing
the medication process system in hospital settings and
pharmacological education of prescribers and nurses could
help to reduce ME. In addition, drug use policy should be
implemented and maintained to reduce inappropriate use
of drugs.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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